FDA ponders adaptive trials

The Wall Street Journal reports that the FDA is developing regulatory guidelines for adaptive trials--trial designs that allow companies to adjust studies as they go based on early results. Currently, the results of clinical trials are secret until the trial is completed and analyzed. In addition, once set in motion, the trial is not stopped or adjusted based on results. Adaptive trials would be a major shift from this approach and could yield millions of dollars in savings for drug developers. "It helps us pick the winners and losers faster," Steve Ruberg, director of global medical information sciences at Eli Lilly, told The Wall Street Journal.

Adaptive trials are not without complications. Statistically and logistically they are much more complex than the current model. There's also a risk of patients or investigators learning of the early results, which could impact the outcome of the study. It will be a challenge for the FDA to provide guidelines that both allow for innovation and protect the accuracy of the trial.

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